The invention relates to a method and apparatus for monitoring, predicting and detecting ovulation during the menstrual cycle of a human female subject and in mammals generally. More specifically, the invention relates to a method and apparatus for predicting the progress of a female subject""s fertility cycle that is based on the measurement and recording of changes in the characteristics and properties of an electrical circuit that result from bringing an oral sensor that forms a part of the circuit into contact with the subject""s saliva.
The importance of accurately predicting and detecting the onset of ovulation in fertile females has been recognized for many years. Such information is extremely useful as an aid to fertilization, or to prevent fertilization without the need of contraceptive devices or drugs. The art has recognized the need for a device and for a method for monitoring the ovulation cycle in the privacy of the subject""s home that is simple to use, reliable, inexpensive and non-invasive.
The Office of Technology Assessment (OTA), an agency of the Congress of the United States, estimated that from 2-3 million American couples want to have a baby, but either need medical help to have one or will remain unable to have one. While there has been no increase in the overall incidence of infertility in recent years demand for infertility servicesxe2x80x94mostly conventional medical and surgical rather then in-vitro fertilization (IVF) or other new technologyxe2x80x94has steadily increased, with between 300,000 and one million couples annually seeking help. Still, as many as half of the couples seeking treatment for infertility will ultimately be unsuccessful, OTA says.
Americans spent about $1 billion on medical care to combat infertility in 1987, according to the Agency. Less then 1% of all couples seeking infertility treatments try IVF, OTA says; there was some 14,000 attempts at IVF in 1987, involving about $66 million of the $1 billion outlay.
Among infertile couples seeking treatment, 85-90% are treated with conventional medical and surgical therapy. Medical treatment ranges from instructing the couple in the relatively simple methods of pinpointing ovulation to more complex treatments involving ovulation induction with powerful fertility drugs, and artificial insemination (AI). Ovulation induction, surgery, and AI are the most widespread and successful approaches to overcoming infertility.
Two non-coital reproductive technologiesxe2x80x94in-vitro fertilization (IVF) and gamete intrafallopian transfer (GIFT)xe2x80x94offer hope to as many as 10-15% of the infertile couples who could not be successfully treated otherwise. These techniques are being practiced with increasing frequency, but proficiency varies widely.
Some 10 to 80 medical teams in the U.S. have established a record of some success with artificial insemination (AI) and invitro fertilization (IVF), and proficiency with GIFT is increasing. However, the remainder of the 169 IVF/GIFT programs in this country have has little or no success to date. It is apparent that whether the infertility problem is treated with simple or complex treatments, a reliable and accurate method of pinpointing conception is a precisely timed biological event, infertility diagnosis and treatment often involve costs of time away from work, and may involve travel, hospital and hotel costs. The proposed device will reduce the time and costs to infertile couples because it allows couples to pinpoint ovulation at home with a high degree of accuracy and minimal or no medical or professional supervision.
The task of predicting ovulation or the fertile period, therefore, appears to be quite important. One needs only to measure alterations in important to marker molecules in any of a number of biologic fluids that would define the limits of the fertile period or, specifically, ovulation. However, defining these limits involves establishing the life span of both gametes involved in the fertilization process. Estimates of sperm viability in the female reproductive tract range from 2 to 7 days. Unfortunately, good data for such estimates are scarce. In reality, the life span of the ovulated ovum has been suggested to be only as long as 72 hours. However, institutions practicing in-vitro fertilization suggest the mature ova more than 24 hours old (perhaps only 12 hours) are generally incapable of being fertilized and/or producing viable offspring, but their in-vivo life span may be considerably more. Thus, the period of fertility in most women may be from 7 days prior to ovulation to possibly 3 days after. Unfortunately, without more information about functional sperm survival in the female reproductive tract, this interval will continue to be uncertain. Good predictors of this ovulation, therefore, would mark this span of time by being able to coincidently detect changes in more then one hormone or other molecules in biological fluids. Since steroid hormones are produced by the developing graafian follicle and corpus luteum, plasma concentrations of these or their urinary metabolites would be useful markers, and measurements of either plasma or urinary LH or FSH may be helpful, since it is these alone or in combination that lead to follicular and ovum maturation and to ovulation itself. Furthermore, since estrogens and progesterone have a wide variety of biological functions, one might speculate that molecules acutely responsive to their plasma concentration may be useful as fertile period indicators. Also, one would expect that a truly specific indicator of the fertile period and/or ovulation would be a product of the dominant follicle, since it is destined to become the parent of the ovum at ovulation. Changes in electrolyte concentration in various biological fluids (saliva and vaginal mucus) have also been reported as a function of ovulation.
In addition, techniques needed to measure these changes in hormones or hormone- responsive markers must be sensitive, specific, cost-effective, easy to perform as applicable to a clinical or diagnostic setting in which sophisticated equipment is unavailable. The interval of time between samples taken for monitoring also must be considered. The efficacy of predicting the fertile period may increase with a decreasing sample-to-sample interval, and the longest interval allowed to give optimal predictability of a given variable to establish the fertile period must be clearly defined. From known rhythms of alterations in plasma, saliva, and urinary hormones, it appears that the successful monitoring of steroids, peptide, and other factors for the prediction of ovulation would require a daily, or perhaps twice daily, sampling. Under those conditions one could expect to accurately predict the fertile period in at least 90% of normally cycling women. Finally, since no methodology will be successful if it is used incorrectly, it is essential that ovulation prediction techniques be developed that will minimize inconvenience to the user.
Ogino and Knaus showed that regardless of the length of the individual""s cycle, the timing of ovulation is relatively constant with respect to the onset of the next menses, but not necessarily with respect to the previous menses. From these studies, both developed formulas to determine a woman""s fertile and infertile days on the basis of her own cyclic variations. This marked the beginning of xe2x80x9crhythmxe2x80x9d as a valid contraceptive method.
The greatest problem with calendar rhythm is that few women have regular 28-day menstrual cycles. Therefore, timing an eventxe2x80x94ovulationxe2x80x9414 days in advance of another event which does not occur with complete regularity is difficult in theory and often impossible in practice. An exact record of at least 6 menstrual cycles, or preferably 12, is necessary even for initial calculations. Thus, for a woman with a menses of 4 days duration, which varied over a 12-month period from intervals of 26 and 31 days, only 12 to 18 cycles would be safe for intercourse including the days of menstruation.
Unlike the calendar method, which depends primarily on the regularity of the menstrual cycle, the thermal or temperature method depends upon identification of a single eventxe2x80x94the rise in basal body temperature (BBT). This occurs at the time of ovulation as a result of the elevated progesterone level. The basal body temperature refers to the temperature of the body at complete rest. It varies from person to person and within each individual depending on the time of day, year, the surrounding climatic temperature, and in women, on the phase of the menstrual cycle.
To practice these methods, a woman must be aware of the sensations of xe2x80x9cdrynessxe2x80x9d and xe2x80x9cwetnessxe2x80x9d in the external parts of the vagina during the different phases and must differentiate between feelings of xe2x80x9cstickinessxe2x80x9d and of xe2x80x9clubrication.xe2x80x9d If she wants confirmation of her sensations she can wipe her vagina with a tissue before urination and examine the physical properties of the mucus, but she is advised not to depend solely on tactile examination of the vagina.
A more quantitative cervical mucus conductivity device has recently been promoted as providing a method of estimating the fertile period. The operation of the device, known as the Cue Fertility Monitor, is based on the hypothesis of changing estradiol and/or progesterment. As estrogen levels rise in the pre-ovulatory period, mucus conductivity rises, and then falls with increasing progesterone concentration. The Cue method uses both vaginal and salivary electrical resistance to predict not only ovulation, but also the pre-ovulatory period for up to one week prior to ovulation. The premise is that peek salivary ion concentration occurs 6-7 days prior to ovulation and then declines throughout the remainder of the menstrual cycle. Vaginal ion concentrations apparently reach their nadir approximately one day before ovulation and then rise significantly. As will be described in more detail below, the Cue Fertility Monitor has been promoted as giving advance notice of ovulation, but it requires vaginal measurements in addition to the saliva measurements to confirm the time of ovulation.
Effectiveness: The condom has a failure rate of about 2% when used as directed. Typically, it has a failure rate of about 12%. For close to 100% protection, the condom should be combined with spermicidal foam, cream or jelly.
Cost: The price for latex condoms may range from $3 to $18 for a dozen. Skin condoms may range from $2 or more each. Other brands may cost more.
Heath Affects: Condoms may produce an allergic reaction.
Effectiveness: The typical failure rate is about 18%. Effectiveness can be enhanced if the women""s partner also uses a condom.
Cost: The cost of the diaphragm may range from $12 to $25. The medical examination and the fitting of the diaphragm can cost from $50 to $100. Spermicidal jellies and creams that are used with the diaphragm begin at about $8.
Health Effects: Some women have a slightly increased risk of repeated urinary tract infections, which may be caused by the pressure of the rim on the urethra or spermicide. Diaphragms can also be vaginal trauma. It causes a disruption of the vaginal epithelium, which leads to lesions on the vaginal walls, which can serve as places for the proliferation of microorganisms.
Effectiveness: The failure rate ranges from 8% to 19%. To increase effectiveness the woman""s partner may also use a condom.
Cost: The cervical capo ranges from $30 to $40. The medical examination involving a preliminary pelvic examination, PAP test and fitting can range from $30 to $100.
Health Effects: There is a theoretical risk of toxic shock syndrome if the cap is worn more then 72 hours. The regular use of the cervical cap can lead to the vulnerability of the epithelium, the cell layer that lines the cervix, to the human papoilloma virus. This may then lead to cervical cancer. There is also a risk that the cap may irritate the cervix.
Effectiveness: The typical failure rate is about 18%. This rate increases for women who have previously given birth.
Cost: The cost is approximately $1.50 per sponge. They are usually sold in packages of 3, 6, or 12.
Health effects: there is a small chance of toxic shock syndrome. The sponge may tear if worn more than 48 hours. Allergic reaction may also occur. Since the sponge absorbs vaginal fluid during the intercourse, it may lead to vaginal dryness.
Effectiveness: They have a first year failure rate of about 21% to 22%.
Cost: Creams and jellies range from $7 to $13. Foams cost between $9 and $11 per can.
Health Effects: They may cause irritation or allergic reactions
Effectiveness: It should be taken every day at approximately the same time. A Pill that includes synthetic estrogen is extremely effective. A Pill that contains at least 30 mcg of estrogen has about 1% to 2% failure rate. Pills that contain 20 mcg of estrogen have failure rate of 2%. The effectiveness of oral contraceptives can be lessened by a number of commonly prescribed drugs.
Cost: Physical examination range from $50 to $150 plus charges for the necessary laboratory test. The cost of refilling a birth control prescription may range from $12 to $30 for a month""s supply.
Health Effects: The use of oral contraceptives can lead to the development of cardiovascular complications. It may also lead to an increased risk of cervical dysphasia (abnormal cell changes) and cervical cancer.
Pills can also cause cervical erosion, which will lead to chlamydeous cervicitis. The pill may accelerate gallbladder problems for women who are prone to this disorder. The pill has been associated with an increase in the incidence of rare liver tumors and liver cancer.
The pill has side effects such as nausea, Vaginitis, Urinary Tract Infection, changes in menstrual flow, breakthrough bleeding, breast-feeding problems, headaches, diabetes, breast swelling, fluid retention, weight gain, depression, and skin problems, gum inflammation, and virus infections.
Effectiveness: The failure rate is about 2% to 3%. This rate decreases with age.
Cost: Physical examination can range from $50 to 150 not including the charges for laboratory test. Progestin-only pills cost about $25 to $45 for a month""s supply.
Health effects: Functional Ovarian cysts may develop. There is a greater risk of Entopic Pregnancy if pregnancy occurs during the use of the mini-pill. The most common side effect of the mini-pill is menstrual disturbances. The effects seen with the combination pill also occur but are less common with the Progestin-only pill: headaches, weight gain, cervical erosion, jaundice allergic reaction, depression, gastrointestinal disturbances, and breast changes.
Effectiveness: The pregnancy rate is 0.2% in the first year of use, 0.5% for the second year, 1.2% for the third year, and 1.6% for the fourth year. The overall effectiveness rate for the entire five years is 96%. Women who weigh over 154 pounds have an increased risk (5.1%) of pregnancy beginning in the third year of use.
Cost: Norplant implants cost $350. There is also a cost for insertion ($150 to $200) and removal ($70 to $150); If Norplant is used for all five years, the cost averages to about $100 per year.
Health effects: There are side effects such as irregular menstrual bleeding, cholesterol changes, headaches, functional ovarian cysts, weight changes, infection at the site after insertion, expulsion of one or more capsules from under the skin, and mood changes. Some uncommon side effects include acne, unwanted hair growth, nervousness, nausea, dizziness, changes in appetite, and hair loss.
Effectiveness: The typical failure rate is 3%. This percentage is lower among women over thirty. The two types of IUDs are Progestasert and ParaGard. The Progestasert has a failure rate of about 2%. The ParaGard has a failure rate of less than 1%.
Cost: Costs range from about $100 to $600. This includes the IUD itself, counseling, a physical exam, blood tests, and insertion.
Health Effects: There is a risk of Pelvic Inflammatory Disease. Pregnancy can occur, and if it does there is a risk of an n entopic pregnancy. Peroration can occur unb which the IUD can perforate the uterus (or cervix). It maybe expelled. It may become embedded in the lining of the uterus. It may cause side effects such as bleeding, cramping, and pain.
Effectiveness it is more than 99% effective.
Cost: The cost of a tubal occlusion can range from $700 to $3,000.
Health Effects: Major complications are infrequent. Complications can result from the surgery itself, such as infection, internal bleeding, or damage to organs and tissues. The most common long-tern complication of tubal sterilization is an entopic pregnancy.
Effectiveness: There is a failure rate of 0.5% to 1%.
Cost: A vasectomy costs between $300 and $1,000.
Health Effects: Complications are rare. The most common complication is a hematoma, which is a mass of clotted blood. An infection may develop (1.5% to 3.4%) near the site of the incision. Epididymitis occurs in 0.3% of cases.
From the above summary description, it will be apparent that substantial research efforts and expenditures have been made and are continuing to be made in connection with the effects of infertility, fertility and population control. Many of the problems associated with these issues could be resolved if there existed a reliable means of determining or predicting in advance when ovulation was going to occur.
In view of the above, various methods have been disclosed in the literature for predicting ovulation or the progress or stage of the subject""s fertility cycle that are based on measuring changes in, or the values of any of a number of biological fluids that define the limits of the fertile period or, specifically, ovulation. However, defining these limits involves establishing the life span of both gametes involved in the fertilization process. Estimates of sperm viability in the female reproductive tract range from 2 to 7 days. Unfortunately, good data for such estimates are scarce. In reality, the life span of the ovulated ovum has been suggested to be only as long as 72 hours. However, institutions practicing in-vitro fertilization suggest that mature ova more than 24 hours old (and perhaps only 12 hours) are generally incapable of being fertilized and/or producing viable offspring. Other authorities suggest that their in-vivo life span may be considerably longer. Thus, the period of fertility in most women may be from 7 days prior to ovulation to possibly 3 days after. Unfortunately, without more information about functional sperm survival in the female reproductive tract, this interval will continue to be uncertain. Good predictors of ovulation, therefore, mark this span of time by being able to coincidentally detect changes in more then one hormone or in other molecules in biological fluids. Since steroid hormones are produced by the developing graafian follicle and corpus luteum, plasma concentrations of these or their urinary metabolites can be useful markers, and measurements of either plasma or urinary LH or FSH may be helpful, since it is these alone, or in combination, that lead to follicular and ovum maturation and to ovulation itself. Furthermore, since estrogens and progesterone have a wide variety of biological functions, it has been suggested that molecules acutely responsive to their plasma concentration may be useful as fertile period indicators. Also, it would be expected that a truly specific indicator of the fertile period and/or ovulation would be a product of the dominant follicle, since it is destined to become the parent of the ovum at ovulation. Changes in electrolyte concentration in various biological fluids, including specifically saliva and vaginal mucus, have also been reported as functionally related to the onset of ovulation.
In addition, techniques needed to measure these changes in hormones or hormone- responsive markers must be sensitive, specific, cost-effective, easy to perform as applicable to a clinical or diagnostic setting in which sophisticated equipment is unavailable. The interval of time between samples taken for monitoring must also be considered. The efficacy of predicting the fertile period should increase with a decreasing sample-to-sample interval, once the longest interval allowed to give optimal predictability of a given variable to establish the fertile period is defined. From known rhythms of alterations in plasma, saliva and urinary hormones, it appears that the successful monitoring of steroids, peptide, and other factors for the prediction of ovulation requires a daily, or even twice daily, sampling. Under optimum conditions one could expect to accurately predict the fertile period in at least 90% of the subjects having a normal fertility cycle. Finally, since no methodology can be successful if it is used incorrectly or inconsistently, it is essential that the ovulation prediction method and apparatus be of minimum inconvenience to the subject and that it require minimal manipulation by the subject.
Various methods of predicting ovulation based on biochemical changes in body fluids, such as vaginal mucus, urine or saliva, have been proposed. For example, U.S. Pat. No. 3,434,801 discloses a test for chloride ion concentration that is indicative of sodium chloride concentration; U.S. Pat. No. 4,385,125 proposes a method of detecting ovulation by monitoring dodecanol concentrations in saliva; U.S. Pat. No. 5,914,271 discloses monitoring calcium and magnesium concentrations in saliva as an ovulation predictor; and U.S. Pat. No. 5,109,865 discloses a device for measuring sodium ion concentration in vaginal mucosa to determine pregnancy. It is also known from the literature that the concentration of sodium and potassium-containing compounds in the human female""s saliva vary with her menstrual cycle. During ovulation, the concentration of sodium and potassium ions reaches a maximum. Measuring the variation in concentration can give a precise indication of the fertile period and the ovulation time. However, as disclosed in U.S. Pat. No. 4,770,186, the method of measuring the concentration of specific ions is expensive and not readily accomplished in a portable, hand-held device that must be used on a daily basis.
The above-described and other methods and apparatus for predicting the advance of a female subject""s fertility cycle are based on direct measurement of one or more compounds in the subject""s saliva or other bodily fluid. These methods are direct, i.e., the saliva is analyzed directly for the presence of a particular chemical compound or biological material. An alternative method is by indirect measurement, as by measuring another property that is affected by the composition of the saliva. One such indirect method is disclosed in U.S. Pat. No. 4,770,186 (xe2x80x9cthe 186 patentxe2x80x9d) and employs the subject""s saliva to complete the circuit between a plurality of conducting elements in a probe that is placed in the subject""s mouth. The disclosure of U.S. Pat. No. 4,770,186 is incorporated herein by reference. Using appropriate circuitry, the relative resistivity as measured by the same probe is recorded on a daily basis and a plot of the so-called xe2x80x9csaliva electrical resistivityxe2x80x9d, or xe2x80x9cSERxe2x80x9d, is prepared. As reported in this disclosure, the value of the resistivity increases and decreases in a predictable pattern in relation to the days before and days following ovulation. Again, according to the disclosure, the pattern is sufficiently consistent from one period of ovulation to another to permit the subject to make a visual determination, or at least an estimation of when ovulation will occur based upon the data points plotted. The numerical values of the SER observed by the subject are graphically plotted on the vertical or Y-axis and the days before and days after the day of ovulation are plotted on the horizontal or X-axis.
According to the disclosure of the ""186 patent, the absolute values of the SER will vary among subjects who are at precisely the same stage in their respective cycles and it is therefore necessary to look at the graphical plots or relative values of the historical SER data to predict the subject""s fertile period. When the SER values are plotted against the days to ovulation, it is stated that a generally consistent pattern is observable from one cycle to another, and that each cycle can be divided into a series recognizable stages or zones. However, the method described in the ""186 patent also requires the accumulation and recording of similar daily electrical resistance data for the subject""s vaginal fluids in order to provide an accurate and reliable prediction of the fertile period. It has also been determined that the measured values of the SER are subject to variations caused by factors other than the stage of the subject""s menstrual cycle. The variations can be caused by changes in the subject""s general health, stress, and the like. As will be understood by one of ordinary skill in the art, such variations will have an adverse effect on the pattern or plot of the SER values with the result that the data becomes unreliable as a basis for predicting the fertile period.
It has also been found, contrary to the specific teachings of the ""186 patent, that the plotting of electrical resistivity of the vaginal mucus is a much more reliable and accurate indicator of the ovulation cycle than the SER method. In this regard, it is now known that the differences in electrical resistivity of the vaginal mucus are greater and produce a more significant change during the critical periods of the subject""s fertility cycle than is suggested by the disclosure of the ""186 patent.
A device for making and recording quantitative cervical mucus conductivity measurements has been promoted for predicting the fertile period. The device, offered commercially as the Cue Fertility Monitor, measures both vaginal and salivary electrical resistance to predict not only ovulation, but also the preovulatory period for up to one week prior to ovulation. The cost of this device is relatively expensive and questions regarding its reliability, ease of use and the subject""s ability to interpret the readings have been raised. Although the Cue Fertility Monitor has been promoted as giving advance notice of ovulation based on use only of an oral probe in contact with the saliva, reports suggest that measuring salivary electrical resistance alone using the Cue device is not reliable and that vaginal measurements are required to accurately predict the time of ovulation. However, as suggested in the literature of the prior art, it is much more desirable to employ a method and apparatus in which the subject can use an oral sensor or probe to contact her saliva, than it is to rely upon a method and apparatus that requires contact with the vaginal mucous.
It is, therefore, a principal object of the present invention to provide a method and apparatus for reliably and consistently predicting and detecting ovulation in which the subject""s saliva is employed to indirectly provide data related to the progress of the subject""s fertility cycle and to the subject""s stage in the fertility cycle.
Another object of the invention is to provide an improved method and apparatus for determining the stage of the subject""s fertility cycle that is based on a parameter whose changes during the cycle are substantially linear.
It is a further object of the invention to provide a method and associated apparatus that is based on the measurement of a characteristic of the saliva on at least a daily basis, and the visual display of data or other indicia derived from such measurements that will provide an accurate prediction of the subject""s fertility cycle and the contemporaneous stage of the cycle.
It is also an object of the invention to provide a device by which the subject utilizes a non-invasive, single-use disposable sublingual, lingual or bucal probe to obtain at least a daily measurement of a characteristic of the saliva and the device provides a visual display from which the subject can determine with reliability the stage of her fertility cycle.
An additional object of this invention is to provide a user-friendly, self-interpretive device and method to predict and confirm ovulation and the fertility cycle.
Another object of the invention is to provide a reliable, inexpensive disposable oral sensor for use in the method and apparatus.
A further object is to provide a subject with an historical record of monitoring data that will be of use in the proper treatment of subjects with fertility problems and to permit them to monitor the progress of any treatment and any improvement in her condition.
Another object of the invention is to provide a hand-held, portable, battery-powered device that does not impose any environmental or personal restrictions on the time, place or manner of its use.
A still further object is to provide an inexpensive, simple and accurate method and apparatus for monitoring and predicting ovulation, that is a useful means for birth control.
The above objectives, as well as other benefits and advantages, are achieved by the present invention which provides a method and apparatus for predicting and identifying the fertile period of human female subjects and other female mammals. In a preferred embodiment, the invention provides a direct visual display of the interpretations of one or more daily measurements utilizing a disposable oral sensor in combination with an electrical circuit, a programmed microprocessor, memory and display device.
In its most elemental form, the invention utilizes an oral sensor that, together with novel electrical circuit, measures the change in frequency in the circuit due to the contact of the oral sensor with an electrolyte in a liquid medium, i.e., the subject""s saliva. The amount and direction of the change in frequency varies with the concentration of electrolytes in the medium. An indicator displays the change in frequency, or in a preferred embodiment of the apparatus, analyzes the change in frequency and display its results.
A method of indirectly monitoring changes in concentration levels of electrolytes on a medium is provided. An oral sensor whose apparent capacitance varies with the concentration level of the electrolytes is provided. A means of relating the changes in electrolytes concentration by detecting changes in the oral sensor""s effect on an oscillator circuit is also provided.
An oral sensor for use in monitoring concentration levels of electrolytes is also provided. A capacitor-like element, the oral sensor""s characteristics vary with the concentration of electrolytes. The oral sensor is used with devices that detect changes in the oral sensor due to the concentration level. One preferred type of detection device uses an oscillating circuit of which the oral sensor is a component.
The method and apparatus operate on the principle of indirect measurements of the properties of the subject""s saliva which vary in a predictable pattern during the fertility cycle. Significantly, the indirect measurements of the characteristic of the electrical circuit are found to produce a more nearly linear plot than other methods and techniques described by the prior art. Most importantly, the combination of the oral sensor design and the electrical characteristic chosen for measurement produce a synergistic result, so that the reliability of the data and associated tabulations are not affected by factors such as the subject""s illness, an injury, physical or mental stress, diet, and the like.
The oral sensor of the invention is so constructed that it most nearly resembles a capacitor, and will be referred to herein as a xe2x80x9ccapacitive oral sensorxe2x80x9d or, for convenience, simply as an xe2x80x9coral sensorxe2x80x9d. As used herein, xe2x80x9ccapacitive oral sensorxe2x80x9d means a component for use in an electrical circuit and that is of an appropriate size and shape to be placed in the subject""s mouth to be intimately contacted and preferably coated, at least in part, by the subject""s saliva. The oral sensor of the invention is formed from a pair of exterior layers of conductive material that are electrically isolated or insulated from each other. Positioned between the first and second exterior layers is a third interior layer of conductive material that is electrically isolated from one of the exterior conductive layers by a layer of non-conductive material and spaced from the other exterior conductive layer by a perforated non-conducting layer of material so that the surface of the third interior layer of conducting material is in contact with one of the exterior layers in the region of the perforations. The third interior layer of conducting material is also perforated so that the two opposing layers of non-conducting material are in contact with each other in the region of the perforations. When the capacitive oral sensor of the invention is incorporated in an oscillator circuit and placed in contact with an electrically conductive solution, or electrolyte, containing sodium ions, e.g., aqueous sodium chloride, it produces a substantially linear change in frequency, df, in the circuit.
The capacitive oral sensor constitutes a part or component in an oscillator circuit that operates at one design frequency when a fresh oral sensor is installed and at a different frequency when the oral sensor is brought into contact with the subject""s saliva. The invention comprehends a method that is based on measuring and recording frequency changes based on daily readings to first establish a baseline of data for her menstrual cycle, that in one embodiment, can be displayed graphically; and subsequently, to compare daily frequency changes, or differences in frequency, df, with the baseline data to predict and display the subject""s current status relative to her menstrual cycle.
The invention is preferably housed in an appropriately configured hand-held device, is battery-powered and is portable so that it can easily be transported in a purse or luggage when the subject is traveling. The apparatus also includes an appropriately programmed microprocessor/controller, memory, display means and frequency-measurement means provided for the purpose, along with novel algorithms to process the measurements and which can predict ovulation 5-8 days in advance. The apparatus and method accurately measure and analyze salivary properties utilizing only an oral sensor, algorithms and a microprocessor/controller. The invention obviates the need for invasive vaginal measurements and the attendant fear of vaginal infection.
The recruitment of dominant follicle in the female""s ovaries causes significant changes in bodily fluid electrolytes. The capacitive oral sensor of the invention indirectly measures the changes in bodily fluid electrolytes in the saliva by use of an oscillator circuit and a related processor and algorithms adapted to measure frequency values and differences, record the data and compare it to historical baseline and other historical data. This indirect measurement is made in terms of the frequency change in an oscillator circuit that is designed for use in conjunction with the oral sensor. When compared to a baseline of data obtained for the subject, the measurement of these changes are utilized to predict ovulation five to eight days in advance. A reliable and accurate ovulation prediction device can be used by couples trying to conceive or, conversely, to avoid pregnancy, i.e., for contraception.
The method of the invention uses the measured variation in frequency due to changes in the permeability of the non-conducting dielectric material used in the capacitive oral sensor. As presently understood, when the concentration of sodium ion and other electrolyte changes with the biological change of the female, the frequency of the oscillator circuit will change when the oral sensor is wetted with the subject""s saliva.
In a preferred embodiment, the apparatus includes a housing with a display panel located on the top front or face. An on/off switch is located toward or on the right side wall for easy access by the subject. The oral sensor socket is located in or adjacent the top wall of the unit. The oral sensor is provided with electrical conducting leads adapted to be received in the oral sensor socket. A start button or switch can also be located on the front or sidewall. It is conveniently located to be used by the thumb of the same hand. It is pushed instantaneously after the oral sensor is in the mouth. Power for the device is preferably supplied by a 7.2 VDC (9 VDC nominal) battery that should last for about 6 months with an average of three minutes of daily use.
The device is equipped with non-volatile memory that can store up to three years of daily measurements. The accumulated data can be downloaded to a personal computer via an internal connector and appropriate software in response to a switch or coded signal transmitted to the microprocessor for this purpose.
The change in frequency (df) is monitored daily and a new or fresh oral sensor is installed in the circuit before each daily measurement. The daily frequency measurement data is recorded in the memory of associated data storage means and is processed and compared with other historical data, i.e., the data taken on previous days, and the change in frequency recorded, compared with the historical or baseline df and an appropriate signal generated and transmitted to the display means. As will be described in more detail below, the significance of having successive frequency change measurements going up or down signifies the beginning of each successive stage of the fertility cycle before or after the time of ovulation.
If a preferred embodiment, a limited access reset button is provided so that when the unit is used by another subject, the device can be reset to start accumulating data for the new subject. All the old data of the previous subject can either be erased or transferred to another data storage register associated with the first subject""s personal identifying indicia.
The method and apparatus of the invention can be used with mammals other than humans. The menstrual cycles of most mammal species that have been kept for food, breeding as pets, zoological specimens and the like, have been documented. Data can be gathered on a daily or other regular basis that is relevant to the fertility cycle of the mammal and the purpose, e.g., for natural or artificial insemination when the female animal is in the fertile stage. The size and configuration of the oral sensor can be adapted for use with different types of animal. For example, the oral sensor support structure can be made larger and able to withstand biting or chewing by the subject. Instead of being inserted directly into a housing that also contains the circuitry, power supply and display means, the oral sensor can be incorporated into a hand-held probe that is connected by a shielded cable to a remote device; or the probe can include a portable power supply, e.g., a battery and digital memory means for recording the frequency data, which is later downloaded for processing in a remote device.
The invention thus provides a method of birth control by indirectly monitoring concentration levels of electrolytes in saliva with an oral sensor that changes the frequency of an associated oscillator circuit when in contact with the saliva. Interpreting the change in frequency indicates the onset of ovulation.